Melatonin as an Analgesic in Preterm Neonate

Ain Shams University

Status: Enrolling

Conditions: Preterm Neonate Analgesia

Treatments: Drug: Melatonin 10 mg

Study type: Observational

Funder types: Other

Identifiers

NCT05971485

FMASU MS 496/2022

Details and patient eligibility

About

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, and antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of melatonin during venous cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure, and to demonstrate the significant relationship between procedural pain and Malondialdehyde (MDA), a well-accepted marker of oxidative stress through measuring MDA after 60 minutes of the procedure.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infant
• less than 37 weeks gestational age
• who started enteral feeding.

Exclusion criteria

• Multiple congenital anomalies.
• Facial malformation.
• Receiving analgesia or sedation.
• Contraindication of enteral feeding.
• Clinical or laboratory signs of sepsis.
• Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.

Trial design

40 participants in 2 patient groups

Melatonin group

Description:

Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.

Treatment:

Drug: Melatonin 10 mg

Control group

Description:

Preterm neonates will undergo venous cannula insertion without giving melatonin before the procedure.